RCT of HeartBot in Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HeartBot II Program, Waitlist Control.
- Who it may be relevant to
- Registry conditions: Participants Must be Women Aged 25 Years or Older, Participants Should Have no Self-reported History of Heart Disease or Stroke, Participants Should Have no Terminal Illness or Diagnosed Cognitive Impairment, Including Alzheimer's Disease, Participants Should Not be a Healthcare Professionals or Healthcare Trainees. Basic parameters: from 25 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of the Artificial Intelligence HeartBot II in Increasing Awareness and Knowledge of Heart Attack in Women: Study Protocol for a Randomized Controlled Trial With a Waitlist Control
Overview
The goal of this clinical trial is to find out whether an app-based program called HeartBot II, which uses an artificial intelligence (AI) chatbot, can help improve women's awareness and knowledge of heart attacks in women. This is an online study with about 200 women taking part. Participants will be randomly assigned (by chance) to one of two groups: an intervention group or a wait-list control group. Participants in the intervention group will begin using the HeartBot II program right away. Participants in the wait-list control group will wait 12 weeks before starting the HeartBot II program. The HeartBot II program includes four short modules. In each module, participants will interact with a chatbot and spend about 10 to 15 minutes completing the content. Participants will be asked to complete an online screening and baseline survey at the start of the study, as well as two follow-up surveys at 12 weeks and 24 weeks.
Detailed description
We conducted a series of studies to evaluate the feasibility, acceptability, and potential efficacy of an AI chatbot (HeartBot I) in increasing women's awareness and knowledge of heart attack symptoms and appropriate care-seeking behavior. The results of those studies and HeartBot I design details were published elsewhere. In brief, HeartBot I was feasible (i.e., no withdrawal from HeartBot I conversation) and accepted by women, and its interactions were significantly associated with improvements in awareness and knowledge of all heart attack outcomes. However, since HeartBot I was a rule-based chatbot, its behavior and responses were limited to content authored specifically for HeartBot I conversations. To improve HeartBot I's capacity, we incorporated all women's heart attack and relevant questions collected in our previous studies and expanded its knowledge bank to enable more educational conversations. To achieve more human-like natural and personalized conversations, we implemented a new version of HeartBot (HeartBot II) powered by an LLM, specifically gemini-2.5-flash through the Google Conversational Agents platform.
Interventions
- Other HeartBot II Program
Participants assigned to the intervention group will receive the HeartBot II intervention during the first 12 weeks. Participants in the intervention group will download the HeartBot II application on their smartphone, register their account with the access code provided by the research team, and will be asked to start Module 1 immediately after randomization. The HeartBot II application consists of 4 module and each module is scheduled approximately 3 weeks apart. It will take about 13 minutes - Other Waitlist Control
The waitlist control group will not receive the HeartBot II intervention during the initial 12-week period, but will receive a text message once week for 12 weeks for attention control. These text messages do not include any educational content related to heart attack or heart health and are limited to neutral study reminders and general self-report prompts. Following completion survey at week 12, participants in the waitlist control group will initiate the HeartBot II program, delivered identic
Primary outcome measures
- Awareness and knowledge of symptoms and response to a heart attack [Time frame: Baseline, week 12, week 24]
Secondary outcome measures (2)
- HeartBot II evaluation [Time frame: Baseline, week 12, week 24]
- Perceived risk of heart attack [Time frame: Baseline, week 12, week 24]
Eligibility criteria
Inclusion criteria
- Women
- 25 years or older
- Living in the US
- University of California, San Francisco Health patient
- Possessing a smartphone with a data plan or Wi-Fi access
Exclusion criteria
- Individuals who identify as male
- Having self-reported cognitive impairment
- Having history of heart disease or stroke
- Healthcare professional/trainee
- Working in the healthcare field
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of California, San Francisco — San Francisco
Identifiers
NCT: NCT07416734 · 25-44825